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The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Erythromycin, at concentrations of 0.12 to 16 ug/ml, 0.5-4 ug/ml and 0.5-1, 4 ug/ml for Staphylococci, to the test panel.

The gram-positive organisms which may be used for Erythromycin susceptibility testing in this panel are:

Staphylococcus aureus

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute concentrations of broth, to concentrations bridging the range of clinical interest. Panels are rehydrated with Synergies plus™ Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI, or equivalent, System, or equivalent, for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The text states that the external validation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains." However, the specific sample size (number of isolates/strains) used for the test set is not provided. The data provenance is not explicitly stated as country of origin, but it is clear that it was a prospective study as it describes an "external validation" designed to "confirm the acceptability of the proposed" panel.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The ground truth for the test set was established by a "frozen Reference Panel" and "Expected Results" for challenge strains, but details about the experts involved in creating these references are missing.

4. Adjudication Method for the Test Set:

This information is not provided. The comparison was made to a "frozen Reference Panel" and "Expected Results," but the method of adjudication (e.g., how discrepancies between the test device and the reference were resolved or if there was any expert review of results) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance:

This was not an MRMC comparative effectiveness study. The device described is an automated antimicrobial susceptibility test system, not an AI-assisted diagnostic tool that helps human readers. Therefore, there is no information about human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance study was done. The device is an automated system that determines antimicrobial susceptibility. The study describes the performance of the "MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel" itself, comparing its readings to a reference panel, indicating an algorithm-only performance. The "MicroScan® Instrumentation" is mentioned as reading the panels, further supporting this.

7. The Type of Ground Truth Used:

The ground truth used was based on a "frozen Reference Panel" for efficacy isolates and "Expected Results" for stock challenge strains. These reference methods represent a form of expert consensus or established laboratory standard for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set:

The sample size for the training set is not provided. The document focuses on the validation study.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided. The document describes the validation of the device against reference methods but does not detail how any potential training data or the associated ground truth for such data (if applicable to the development process) was established.

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